The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.
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The authors report the following disclosures: Keith D. Aaronson, MD, research support and speaker fees from HeartWare International, Inc; Michael A. Acker, MD, consultant for Thoratec Corporation; Timothy Baldwin, PhD, no disclosures; Steven Boyce, MD, educational grants from and stock ownership in Thoratec Corporation and HeartWare International, Inc; Elizabeth Blume, MD, no disclosures; Bartley Griffith, MD, no disclosures; Robert Higgins, MD, no disclosures; Mariell Jessup, MD, research on investigational mechanical circulatory support devices within the past 5 years (uncompensated); Robert Kormos, MD, no disclosures; Michael Mack, MD, no disclosures; Douglas L. Mann, MD, no disclosures; Leslie Miller, MD, no disclosures; David Naftel, PhD, Berlin Heart, Inc and HeartWare International, Inc; Francis D. Pagani, MD, PhD, national principal investigator, HeartWare Endurance trial, and national coprincipal investigator, NHLBI REVIVE-IT trial; Joseph Rogers, MD, consultant for Thoratec Corporation and national principal investigator, HeartWare Endurance trial; Mark S. Slaughter, MD, training and educational grant support from Thoratec Corporation and HeartWare International, Inc; Randall C. Starling, MD, MPH, member ROADMAP Steering Committee, and travel reimbursement (<$5,000 per annum) from Thoratec Corporation; Lynne Stevenson, MD, no disclosures; Wendy Gattis Stough, PharmD, no disclosures; Jeffrey Teuteberg, MD, no disclosures; Peter Wearden, MD, PhD, no disclosures; Stephen Westaby, MD, PhD, Medical Director, Calon Cardiotechnology Corporation (uncompensated); and Clyde Yancy, MD, no disclosures.